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CataractPhase 4NCT02633228

Visual Acuity After the Combined Binocular Implantation of +2.0 Diopters and +3.0 Diopters Oculentis Multifocal Intraocular Lenses.

A Phase 4 study testing Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses in people with Cataract, run by PD Dr. med. Eckart Bertelmann at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to assess the visual outcome after the combined binocular implantation of +2.0 D and +3.0 D refractive multifocal intraocular lenses. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cataract
What is being tested?
Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses
Type of treatment
Medical device
How many people
15 participants
Where
1 siteGermany
Study dates
Dec 2014to Jun 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • clinically significant cataract
  • endothelial cell count: patients aged 18-75 years: > 1000 cells/mm2; patients > 75 years: > 750 cells/mm2
  • absence of vision-limiting corneal or retinal comorbidities
  • capability to understand the informed consent

Who cannot join

  • expected postoperative astigmatism > 0.75 diopters
  • irregular astigmatism
  • dilated pupil diameter < 3 mm
  • corneal and fundus abnormalities that might cause visual impairments
  • inability to attend follow-up visits

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité - University Medicine Berlin, Department of Ophthalmology

    Berlin, 13353

Other trials in Germany

About this study

Official title: Evaluation of the Visual Acuity After the Implantation of an Oculentis +2.0 Diopters (Torical) Bifocal Intraocular Lens (MplusX (Toric) LU-313 MF20T/LS-313 MF20) in the Distance Dominant Eye, in Combination With a +3.0 Diopters Oculentis Bifocal Intraocular Lens (MplusX (Toric) LU-313 MF30T/LS-313 MF30) in the Fellow Eye.

The objective of this study is to assess the visual outcome after the combined binocular implantation of +2.0 D and +3.0 D refractive multifocal intraocular lenses.

Read the detailed description

Bifocal multifocal intraocular lenses (MIOL) are effective in achieving good uncorrected visual acuities in the distance and the near. However, the intermediate vision is of increasing relevance for everyday's life. Several multifocal intraocular lenses have been developed to improvement intermediate vision. Nonetheless, those systems still possess adverse photic effects and do not garantuee spectacle independence. Therefore, the combination of a lower-addition bifocal intraocular lense in the distance-dominant eye with a higher-addition bifocal intraocular lense in the fellow-eye might be a promising approach to address these drawbacks of current binocular and trifocal intraocular lenses.

Conditions
Cataract
Being tested
Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses
Keywords
Multifocal Intraocular Lens, Binocular Trifocality, Cataract Surgery, Spectacle Independence, Intermediate Vision, Photopic Vision, Mesopic Vision, Scotopic Vision, Binocular Vision
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lensesDevice

    Also called Oculentis® MplusX® multifocal intraocular lenses with an addition of +2.0 D (LU-313 MF20T/LS-313 MF20) and +3.0 D (LU-313 MF30T/LS-313 MF30) are used.

    Binocular implantation of the combination of Oculentis® MplusX® multifocal intraocular lenses with an addition of +2.0 D in the distance-dominant eye and +3.0 D in the fellow eye.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual acuities in the far, intermediate and near

    Visual acuities are tested under photopic conditions at 5 m, intermediate (80 cm) and patient-preferred near distance (≈ 40 cm).

    Measured: 1 month

  2. Visual acuities in the far, intermediate and near

    Visual acuities are tested under photopic conditions at 5 m, intermediate (80 cm) and patient-preferred near distance (≈ 40 cm).

    Measured: 3 months

  3. Mesopic vision

    Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.

    Measured: 1 month

  4. Mesopic vision

    Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.

    Measured: 3 months

  5. Scotopic contrast sensitivity

    Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare.

    Measured: 1 month

  6. Scotopic contrast sensitivity

    Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare.

    Measured: 3 months

Secondary outcomes (1)

  1. Spectacle independence in the far, intermediate and near

    Spectacle independence as stated by the patient.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionFeb 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02633228
Sponsor's protocol ID
EA2/129/14
Status last verified
Jun 2017
First submitted
14 Dec 2015
Last updated
29 Jun 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Alio JL, Plaza-Puche AB, Javaloy J, Ayala MJ, Vega-Estrada A. Clinical and optical intraocular performance of rotationally asymmetric multifocal IOL plate-haptic design versus C-loop haptic design. J Refract Surg. 2013 Apr;29(4):252-9. doi: 10.3928/1081597X-20130318-04.

    PubMed 23557223

  • Bonaque-Gonzalez S, Rios S, Amigo A, Lopez-Gil N. Influence on Visual Quality of Intraoperative Orientation of Asymmetric Intraocular Lenses. J Refract Surg. 2015 Oct;31(10):651-7. doi: 10.3928/1081597X-20150922-01.

    PubMed 26469073

  • Garcia-Domene MC, Felipe A, Peris-Martinez C, Navea A, Artigas JM, Pons AM. Image quality comparison of two multifocal IOLs: influence of the pupil. J Refract Surg. 2015 Apr;31(4):230-5. doi: 10.3928/1081597X-20150319-02.

    PubMed 25884577

  • Alio JL, Plaza-Puche AB, Pinero DP. Rotationally asymmetric multifocal IOL implantation with and without capsular tension ring: refractive and visual outcomes and intraocular optical performance. J Refract Surg. 2012 Apr;28(4):253-8. doi: 10.3928/1081597X-20120314-01.

    PubMed 22496436

  • Munoz G, Albarran-Diego C, Javaloy J, Sakla HF, Cervino A. Combining zonal refractive and diffractive aspheric multifocal intraocular lenses. J Refract Surg. 2012 Mar;28(3):174-81. doi: 10.3928/1081597X-20120215-02.

    PubMed 22373031

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses in people with Cataract, run by PD Dr. med. Eckart Bertelmann at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual acuities in the far, intermediate and near (time frame: 1 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02633228, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2017.

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